NCT07151950

Obi Medical Robot: Evaluating Effectiveness Related to Usability

Obi Medical Robot: Evaluating Effectiveness Related to Usability in Providers, Caregivers & Patients

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Desin LLC · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

This mixed-methods usability study evaluates the effectiveness of the Obi Gen 3 robotic feeding device in meeting user needs among providers, caregivers, and patients. Participants will complete a one-week trial using Obi in home, school, or community settings, followed by feedback surveys and optional interviews. The study seeks to validate that the device design meets usability requirements prior to broader deployment.

Detailed description

The study assesses the usability of Obi Gen 3 through quantitative surveys and qualitative interviews across three user groups: providers, caregivers, and patients. Measures include the System Usability Scale (SUS), questions based on the Matching Person \& Technology (MPT) assessment and framework, and a custom Obi Medical Device Needs Assessment (MDNA). Data collection includes pre-trial in-office screening and post-trial surveys gathered remotely using Qualtrics. Optional follow-up interviews gather further feedback. The study aims to verify that the Obi Gen 3 meets its intended use and user needs in real-world environments.

Conditions

• Upper Extremity Impairments
• Cerebral Palsy (CP)
• ALS - Amyotrophic Lateral Sclerosis
• Rett Syndrome

Interventions

Type	Name	Description
DEVICE	One-week trial of Obi Medical device, which provides robotic assistance with feeding to persons with upper extremity impairments who are unable to self-feed in the traditional manner using utensils	This study explores the stakeholders' experiences in recommending and using Obi. Stakeholders/Participants include: 1. Persons with disabilities or conditions which prevent them from successfully using their upper extremities (UE) to self-feed independently 2. Caregivers of the persons with disabilities described above 3. Providers (OT, SLP, PT, ATP, etc.) who provide services to persons with disabilities

Timeline

• Start date: 2025-05-10
• Primary completion: 2025-08-12
• Completion: 2025-10-31
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study